Carcinoma, Non-Small-Cell LungPhase 3NCT00254891

Trial of Paclitaxel/Carboplatin + PF-3512676 vs Paclitaxel/Carboplatin Alone in Patients With Advanced Non-Small Cell Lung Cancer

A Phase 3 study testing PF-3512676 + Paclitaxel + Carboplatin and Paclitaxel + Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Pfizer at 191 sites in 26 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel/carboplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety of paclitaxel Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoma, Non-Small-Cell Lung
What is being tested?: PF-3512676 + Paclitaxel + Carboplatin and Paclitaxel + Carboplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 828 participants
Where: 191 sitesin 26 countries
Study dates: Nov 2005to Jul 2008
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Advanced Non-Small-Cell Lung Cancer (NSCLC) stage IIIB with pleural effusion or stage IV
No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC)with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs
Eastern Cooperative Oncology Performance Status (ECOG PS) 0 or 1

Who cannot join

Small cell or carcinoid lung cancer
Known Central Nervous System (CNS) metastasis
Pre-existing auto-immune or antibody mediated diseases

Trial locations and contacts

191 sites in 26 countries.

Country

City, postcode or hospital

191 sites in 26 countries

United States89 sites

Pfizer Investigational Site
Albuquerque, New Mexico, 87109
Pfizer Investigational Site
Allegan, Michigan, 49010
Pfizer Investigational Site
Ann Arbor, Michigan, 48109-0848
Pfizer Investigational Site
Ann Arbor, Michigan, 48109
Pfizer Investigational Site
Arlington, Texas, 76012
Pfizer Investigational Site
Asheville, North Carolina, 28801
Pfizer Investigational Site
Atlanta, Georgia, 30306
Pfizer Investigational Site
Atlanta, Georgia, 30308
Pfizer Investigational Site
Atlanta, Georgia, 30309
Pfizer Investigational Site
Atlanta, Georgia, 30322
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Biddeford, Maine, 04005
Pfizer Investigational Site
Bountiful, Utah, 84010
Pfizer Investigational Site
Brevard, North Carolina, 28712
Pfizer Investigational Site
Brunswick, Maine, 04011
Pfizer Investigational Site
Buffalo, New York, 14263
Pfizer Investigational Site
Burlington, Vermont, 05401
Pfizer Investigational Site
Canton, Ohio, 44718
Pfizer Investigational Site
Cedar Rapids, Iowa, 52403
Pfizer Investigational Site
Chattanooga, Tennessee, 37404-3324
Pfizer Investigational Site
Chula Vista, California, 91911
Pfizer Investigational Site
Columbus, Mississippi, 39705
Pfizer Investigational Site
Corinth, Mississippi, 38834
Pfizer Investigational Site
Covington, Louisiana, 70433
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Dallas, Texas, 75235-7786
Pfizer Investigational Site
Dallas, Texas, 75235
Pfizer Investigational Site
Dallas, Texas, 75390-8590
Pfizer Investigational Site
Dallas, Texas, 75390-9015
Pfizer Investigational Site
Decatur, Georgia, 30033
Pfizer Investigational Site
Dover, Ohio, 44622
Pfizer Investigational Site
Dubuque, Iowa, 52001
Pfizer Investigational Site
Everett, Washington, 98201
Pfizer Investigational Site
Fayetteville, Georgia, 30214
Pfizer Investigational Site
Great Neck, New York, 11023
Pfizer Investigational Site
Gretna, Louisiana, 70056
Pfizer Investigational Site
Hot Springs, Arkansas, 71913
Pfizer Investigational Site
Jefferson, Indiana, 47130
Pfizer Investigational Site
Kalamazoo, Michigan, 49007
Pfizer Investigational Site
Kalamazoo, Michigan, 49048
Pfizer Investigational Site
Kennewick, Washington, 99336
Pfizer Investigational Site
La Mesa, California, 91942
Pfizer Investigational Site
Lafayette, Louisiana, 70503
Pfizer Investigational Site
Langhorne, Pennsylvania, 19047
Pfizer Investigational Site
Las Vegas, Nevada, 89102
Pfizer Investigational Site
Las Vegas, Nevada, 89106
Pfizer Investigational Site
Layton, Utah, 84041
Pfizer Investigational Site
Lexington, Kentucky, 40503
Pfizer Investigational Site
Lexington, North Carolina, 27292
Pfizer Investigational Site
Little Rock, Alaska, 72205
Pfizer Investigational Site
Louisville, Kentucky, 40202
Pfizer Investigational Site
Louisville, Kentucky, 40217
Pfizer Investigational Site
Louisville, Kentucky, 40241
Pfizer Investigational Site
Louisville, Kentucky, 40505-4816
Pfizer Investigational Site
Macon, Georgia, 31217
Pfizer Investigational Site
Madison, Wisconsin, 53792-5666
Pfizer Investigational Site
Marietta, Georgia, 30060
Pfizer Investigational Site
Marrero, Louisiana, 70006
Pfizer Investigational Site
Marrero, Louisiana, 70072
Pfizer Investigational Site
Memphis, Tennessee, 38120
Pfizer Investigational Site
Metairie, Louisiana, 70006
Pfizer Investigational Site
Murray, Utah, 84107
Pfizer Investigational Site
New Albany, Indiana, 47150-6809
Pfizer Investigational Site
New Orleans, Louisiana, 70115
Pfizer Investigational Site
Oceanside, California, 92056
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73112-4491
Pfizer Investigational Site
Omaha, Nebraska, 68114
Pfizer Investigational Site
Omaha, Nebraska, 68124
Pfizer Investigational Site
Omaha, Nebraska, 68130
Pfizer Investigational Site
Palm Springs, California, 92262-4885
Pfizer Investigational Site
Papillion, Nebraska, 68046
Pfizer Investigational Site
Portland, Oregon, 97227-1191
Pfizer Investigational Site
Provo, Utah, 84604
Pfizer Investigational Site
Richardson, Texas, 75080
Pfizer Investigational Site
Richland, Washington, 99352
Pfizer Investigational Site
Rockford, Illinois, 61104
Pfizer Investigational Site
Ruidoso, New Mexico, 88345
Pfizer Investigational Site
Saint Joseph, Michigan, 49085
Pfizer Investigational Site
Salt Lake City, Utah, 84106
Pfizer Investigational Site
San Diego, California, 92123
Pfizer Investigational Site
San Francisco, California, 94115
Pfizer Investigational Site
Scarborough, Maine, 04074
Pfizer Investigational Site
Shelbyville, Kentucky, 40065
Pfizer Investigational Site
Trophy Club, Texas, 76262
Pfizer Investigational Site
Tucker, Georgia, 30084
Pfizer Investigational Site
Tupelo, Mississippi, 38801
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
Pfizer Investigational Site
Worcester, Massachusetts, 01608
Pfizer Investigational Site
WVC, Utah, 84120

Other trials in United States

Australia12 sites

Pfizer Investigational Site
Albury, New South Wales, 2640
Pfizer Investigational Site
Bedford Park, South Australia, 5042
Pfizer Investigational Site
Camperdown, New South Wales, 2050
Pfizer Investigational Site
East Melbourne, Victoria, 3002
Pfizer Investigational Site
East Ringwood, Victoria, 3135
Pfizer Investigational Site
Nedlands, Western Australia, 6009
Pfizer Investigational Site
Pimlico, Queensland, 4812
Pfizer Investigational Site
Randwick, New South Wales, 2031
Pfizer Investigational Site
Toorak Gardens, South Australia, 5065
Pfizer Investigational Site
Townsville, Queensland, 4814
Pfizer Investigational Site
Wodonga, Victoria, 3690
Pfizer Investigational Site
Woolloongabba, Queensland, 4102

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France10 sites

Pfizer Investigational Site
Angers, 49033
Pfizer Investigational Site
Caen, 14033
Pfizer Investigational Site
Dijon
Pfizer Investigational Site
Limoges, 87042
Pfizer Investigational Site
Nantes, 44202
Pfizer Investigational Site
Paris, 75651
Pfizer Investigational Site
Saint-Herblain, 44805
Pfizer Investigational Site
Strasbourg, 67065 Cedex
Pfizer Investigational Site
Toulouse, 31059
Pfizer Investigational Site
Vandœuvre-lès-Nancy, 54511

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Canada7 sites

Pfizer Investigational Site
Moncton, New Brunswick, E1C 6Z8
Pfizer Investigational Site
Montreal, Quebec, H2A 1A1
Pfizer Investigational Site
Montreal, Quebec, H3G 1A4
Pfizer Investigational Site
Montreal, Quebec, H3T 1E2
Pfizer Investigational Site
Montreal, Quebec, H3T 1M5
Pfizer Investigational Site
Rimouski, Quebec, G5L 5T1
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7N 4H4

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Germany7 sites

Pfizer Investigational Site
Berlin, 10117
Pfizer Investigational Site
Bielefeld, 33611
Pfizer Investigational Site
Bonn, 53105
Pfizer Investigational Site
Essen, 45122
Pfizer Investigational Site
Frankfurt, 60590
Pfizer Investigational Site
Karlsruhe, 76137
Pfizer Investigational Site
München, 80336

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Spain7 sites

Pfizer Investigational Site
Alcorcón, Madrid, 28922
Pfizer Investigational Site
Badalona, Barcelona, 08916
Pfizer Investigational Site
Madrid, Madrid, 28041
Pfizer Investigational Site
Madrid, 28007
Pfizer Investigational Site
Pamplona, Navarre, 31008
Pfizer Investigational Site
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38320
Pfizer Investigational Site
Valencia, Valencia, 46014

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United Kingdom7 sites

Pfizer Investigational Site
Exeter, Devon, EX2 5DW
Pfizer Investigational Site
London, SE1 9RT
Pfizer Investigational Site
Portsmouth, PO3 6AD
Pfizer Investigational Site
Sheffield, S10 2SJ
Pfizer Investigational Site
Surrey GU2 5XX
Pfizer Investigational Site
Swansea, SA2 8QA
Pfizer Investigational Site
Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

Greece5 sites

Pfizer Investigational Site
Athens, Attica, 11526
Pfizer Investigational Site
Athens, 115 27
Pfizer Investigational Site
Heraklion, Crete, 71 500
Pfizer Investigational Site
Rio, Patras, 26500
Pfizer Investigational Site
Thessaloniki, Macedonia, 56 403

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India5 sites

Pfizer Investigational Site
Bangalore, Karnataka, 560 034
Pfizer Investigational Site
Chandigarh, Punjab, 160 012
Pfizer Investigational Site
Jaipur, Rajasthan, 302017
Pfizer Investigational Site
Kochi, Kerala, 682 026
Pfizer Investigational Site
Pune, Maharashtra, 411 001

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China4 sites

Pfizer Investigational Site
Beijing, 100021
Pfizer Investigational Site
Beijing, 100071
Pfizer Investigational Site
Dalian, Xigang District, Liaoning, 116011
Pfizer Investigational Site
Shanghai, 200032

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Hungary4 sites

Pfizer Investigational Site
Budapest, 1122
Pfizer Investigational Site
Budapest, 1125
Pfizer Investigational Site
Budapest, 1529
Pfizer Investigational Site
Debrecen, 4032

Other trials in Hungary

Italy4 sites

Pfizer Investigational Site
Lido Di Camaiore (LU), 55043
Pfizer Investigational Site
Milan, 20133
Pfizer Investigational Site
Naples, 81013
Pfizer Investigational Site
Pavia, 27100

Other trials in Italy

Netherlands4 sites

Pfizer Investigational Site
Amstelveen, 1186 AM
Pfizer Investigational Site
Groningen, Provincie Groningen, 9713 GZ
Pfizer Investigational Site
The Hague, 2545 CH
Pfizer Investigational Site
Tiel, Gelderland, 4002 WP

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Portugal4 sites

Pfizer Investigational Site
Faro, 8000-386
Pfizer Investigational Site
Porto, 4099-001
Pfizer Investigational Site
Porto, 4202
Pfizer Investigational Site
Vila Nova de Gaia, 4400

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South Africa4 sites

Pfizer Investigational Site
Cape Town, 7500
Pfizer Investigational Site
Cape Town, 7925
Pfizer Investigational Site
Johannesburg, 2193
Pfizer Investigational Site
Parktown, Gauteng

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Czechia3 sites

Pfizer Investigational Site
Nová Ves pod Pleší, 26204
Pfizer Investigational Site
Ostrava-Poruba, 708 52
Pfizer Investigational Site
Ústí nad Labem, 401 13

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Belgium2 sites

Pfizer Investigational Site
Ghent, 9000
Pfizer Investigational Site
Liège, 4000

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Mexico2 sites

Pfizer Investigational Site
Mexico City, Mexico City, 14080
Pfizer Investigational Site
Puebla City, Puebla, 72530

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Poland2 sites

Pfizer Investigational Site
Otwock, 05-400
Pfizer Investigational Site
Wodzislaw Sl., 44-300

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South Korea2 sites

Pfizer Investigational Site
Seoul, 110-744
Pfizer Investigational Site
Seoul, 120-752

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Sweden2 sites

Pfizer Investigational Site
Stockholm, 118 83
Pfizer Investigational Site
Uppsala, 751 85

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Cyprus1 site

Pfizer Investigational Site
Nicosia, 2006

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Hong Kong1 site

Pfizer Investigational Site
Pokfulam

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Israel1 site

Pfizer Investigational Site
Tsrifin, 70300

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Switzerland1 site

Pfizer Investigational Site
Lausanne, CH-1011

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Taiwan1 site

Pfizer Investigational Site
Taipei, 112

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About this study

Official title: International, Randomized, Open-Label, Phase 3 Trial of Paclitaxel/Carboplatin Plus PF-3512676 Versus Paclitaxel/Carboplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer

Read the detailed description

PF-3512676 dosing was stopped 20 June 2007 in response to DSMC recommendation to close the trial, citing lack of efficacy concerns as the primary reason with a safety issue (sepsis) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 17 July 2008.

Conditions: Carcinoma, Non-Small-Cell Lung
Being tested: PF-3512676 + Paclitaxel + Carboplatin, Paclitaxel + Carboplatin
Keywords: advanced carcinoma, non-small cell lung, Phase III, Paclitaxel, Taxol, Carboplatin, Paraplatin, PF-3512676, immunotherapy, immune modulator
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-3512676 + Paclitaxel + CarboplatinDrug
Also called Taxol; Paraplatin
- PF-3512676: 0.2 mg/kg subcutaneously Days 8 and 15 of each 21 day cycle x 6 cycles then weekly as maintenance until disease progression or unacceptable toxicity.
- Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles.
- Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.
Paclitaxel + CarboplatinDrug
Also called Taxol; Paraplatin
- Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles.
- Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.

Study groups in NCT00254891
Study group	Role	What they receive
A	Experimental	Standard of care chemotherapy plus experiment intervention (PF-3512676) Receives: Drug: PF-3512676 + Paclitaxel + Carboplatin
B	Active comparator	Standard of care chemotherapy Receives: Drug: Paclitaxel + Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival
Measured: 656 Events

Secondary outcomes (6)

Overall Objective Response
Measured: End of Treatment
Time to Tumor Progression
Measured: Time of progressive disease
Progression Free Survival
Measured: Time of primary endpoint
Duration of Response
Measured: Time of progressive disease
Patient Reported Outcomes
Measured: End of Treatment
Overall Safety Profile
Measured: 28 days post PF-3512676 dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2005Jul 2008

First posted17 Nov 2005 (estimated)
Study startNov 2005
Primary completionJul 2008
Study completionJul 2008

Why it stopped: See Termination Reason in Detailed Description

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 828 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00254891
Sponsor's protocol ID: A8501001
Status last verified: Mar 2015
First submitted: 15 Nov 2005
Last updated: 30 Mar 2015
Results posted: No
Data monitoring committee: Yes

Publications

Roeland EJ, Fintelmann FJ, Yang R, Tarasenko L, Bonomi PD. Evaluation of Weight Gain and Overall Survival of Men Versus Women With Advanced Non-Small Cell Lung Cancer. J Cachexia Sarcopenia Muscle. 2025 Dec;16(6):e70131. doi: 10.1002/jcsm.70131.
PubMed 41332393
Roeland EJ, Fintelmann FJ, Hilton F, Yang R, Whalen E, Tarasenko L, Calle RA, Bonomi PD. The relationship between weight gain during chemotherapy and outcomes in patients with advanced non-small cell lung cancer. J Cachexia Sarcopenia Muscle. 2024 Jun;15(3):1030-1040. doi: 10.1002/jcsm.13426. Epub 2024 Mar 11.
PubMed 38468440

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: International, Randomized, Open-Label, Phase 3 Trial of Paclitaxel/Carboplatin Plus PF-3512676 Versus Paclitaxel/Carboplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT00254891
Acronym / sponsor ID: A8501001
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: advanced carcinoma, non-small cell lung, Phase III, Paclitaxel, Taxol, Carboplatin, Paraplatin, PF-3512676, immunotherapy, immune modulator
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: See Termination Reason in Detailed Description
Enrolment: 828 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2005
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 17 Nov 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Drug: PF-3512676 + Paclitaxel + CarboplatinStandard of care chemotherapy plus experiment intervention (PF-3512676)
B	Active comparator	Drug: Paclitaxel + CarboplatinStandard of care chemotherapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Advanced Non-Small-Cell Lung Cancer (NSCLC) stage IIIB with pleural effusion or stage IV
No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC)with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs
Eastern Cooperative Oncology Performance Status (ECOG PS) 0 or 1

Key exclusion criteria (3 listed)

Small cell or carcinoid lung cancer
Known Central Nervous System (CNS) metastasis
Pre-existing auto-immune or antibody mediated diseases

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-3512676 + Paclitaxel + CarboplatinAlso: Taxol; Paraplatin* PF-3512676: 0.2 mg/kg subcutaneously Days 8 and 15 of each 21 day cycle x 6 cycles then weekly as maintenance until disease progression or unacceptable toxicity. * Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles. * Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.	Drug	A
Paclitaxel + CarboplatinAlso: Taxol; Paraplatin* Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles. * Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.	Drug	B

Primary outcome

Overall Survival
Time frame: 656 Events

6 secondary outcomes

Overall Objective Response
Time frame: End of Treatment
Time to Tumor Progression
Time frame: Time of progressive disease
Progression Free Survival
Time frame: Time of primary endpoint
Duration of Response
Time frame: Time of progressive disease
Patient Reported Outcomes
Time frame: End of Treatment
Overall Safety Profile
Time frame: 28 days post PF-3512676 dosing

Results and safety

The study was stopped early (reason given: See Termination Reason in Detailed Description). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
Derived from this study: PubMed 41332393Roeland EJ, Fintelmann FJ, Yang R, Tarasenko L, Bonomi PD. Evaluation of Weight Gain and Overall Survival of Men Versus Women With Advanced Non-Small Cell Lung Cancer. J Cachexia Sarcopenia Muscle. 2025 Dec;16(6):e70131. doi: 10.1002/jcsm.70131.
Derived from this study: PubMed 38468440Roeland EJ, Fintelmann FJ, Hilton F, Yang R, Whalen E, Tarasenko L, Calle RA, Bonomi PD. The relationship between weight gain during chemotherapy and outcomes in patients with advanced non-small cell lung cancer. J Cachexia Sarcopenia Muscle. 2024 Jun;15(3):1030-1040. doi: 10.1002/jcsm.13426. Epub 2024 Mar 11.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

191 sites in 26 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PF-3512676 + Paclitaxel + Carboplatin and Paclitaxel + Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Pfizer at 191 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 191 sites in United States, Australia, France, Canada, Germany and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: See Termination Reason in Detailed Description). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 656 Events). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00254891, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2015.